FDA Issues Final Rules on Sunscreen

WASHINGTON — The Food and Drug Administration today announced stricter
testing procedures for sunscreen manufacturers making claims about
performance and reducing the risk of skin cancer and skin aging.

SN STAFF | Jun 14, 2011

WASHINGTON — The Food and Drug Administration today announced stricter testing procedures for sunscreen manufacturers making claims about performance and reducing the risk of skin cancer and skin aging.

Under the new rules, companies must prove that their formulas provide equal protection against both ultraviolet A (UVA) rays and ultraviolet B (UVB) rays before they can claim "Broad Spectrum" coverage. Only those sunscreens 15 SPF or higher that pass this threshold can claim to reduce the risk of skin cancer and skin aging. Any formula with an SPF value between 2 and 14 that doesn't pass the Broad Spectrum test will require a warning label saying the product has not been proven to protect against skin cancer or skin aging.

Currently, SPF — or sun protection factor — numbers found on sunscreen products indicate protection only against UVB rays, which are the primary cause of sunburn. The FDA noted, however, that both UVA and UVB rays contribute to skin cancer, and that requiring uniform protection under a single claim as opposed to a separate rating system for each, which it had previously proposed, will cut down on confusion.

The FDA also announced a ban on the terms "waterproof" and "sweatproof," saying no formula can completely shield against moisture. Manufacturers can instead claim water resistance for up to 40 or 80 minutes, depending on what test results show.

Companies with yearly earnings of more than $25,000 have one year to comply with the new rules.

First proposed more than three decades ago, in 1978, the FDA's ruling is expected to bring significant changes to the nearly $700 million sunscreen industry. Activist organizations and the medical community have criticized the FDA for the decades-long delay, and some are still concerned about the safety of active ingredients as well as ever-increasing SPF numbers.

While the FDA did not address ingredients or SPF levels in its final rules, the agency did issue a proposed rule limiting the maximum SPF value at "50+" that is open for public comment.